7/31/2024 Updates Meeting
Steering Committee Series
Watch the recording from the meeting.
DC Updates
Loper Bright Enterprises Et Al. v. Raimondo, Secretary Of Commerce, Et Al. (download .pdf)
Letter to Dr. Califf (download .pdf)
Letter to Dr. Shuren (download .pdf)
Congress Must Update FDA Regulations for Medical AI (download .pdf)
Europe Updates
Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 (download .pdf)
Medical Device Competent Authority Statement on the Status of the EU Regulatory System (download .pdf)
FDA
CDRH 2022 - 2025 Strategic Priorities (download .pdf)
Guidance Document July 2024: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers (download .pdf)
Guidance Document July 2024: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations In Clinical Studies Guidance for Industry (download .pdf)
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 (download .pdf)
Guidance Document July 2024: Application User Fees for Combination Products (download .pdf)
Guidance Snapshot: Digital Health Technologies for Remote Data (download .pdf)
FDA Reporting on RWE Submissions to CBER & CDER under PDUFA VII (download .pdf)
MDIC
Learn more about MDIC’s upcoming APF!
Cybersecurity
National Security Agency: Cybersecurity Information Sheet (download .pdf)
ctDNA
Association of personalized and tumor-informed ctDNA with patient survival outcomes in pancreatic adenocarcinoma (download .pdf)
Medicare and Minimal Residual Disease Testing: Case Study for Policy Changes (download .pdf)
Publications
Panacea: A foundation model for clinical trial search, summarization, design, and recruitment (download .pdf)
Accelerating Clinical Evidence Synthesis with Large Language Models (download .pdf)
Navigating Change in Tumor Naming: Exploring the Complexities and Considerations of Shifting Toward Molecular Classifications (download .pdf)
Biomarker testing in early-stage NSCLC: Results from the MYLUNG Consortium (download .pdf)
Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group (download .pdf)
Deep learning models for thyroid nodules diagnosis of fine-needle aspiration biopsy: a retrospective, prospective, multicentre study in China (download .pdf)
AI-based histopathology image analysis reveals a distinct subset of endometrial cancers (download .pdf)
Analysis of 10,478 cancer genomes identifies candidate driver genes and opportunities for precision oncology (download .pdf)
A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial (download .pdf)
The Lancet Commission on prostate cancer: planning for the surge in cases (download .pdf)
CohortFinder: an open-source tool for data-driven partitioning of digital pathology and imaging cohorts to yield robust machine-learning models (download .pdf)
Digital spatial profiling of the microenvironment of muscle invasive bladder cancer (download .pdf)
Validation and three years of clinical experience in using an artificial intelligence algorithm as a second read system for prostate cancer diagnosis—real-world experience (download .pdf)
Benchmarking Embedding Aggregation Methods in Computational Pathology: A Clinical Data Perspective (download .pdf)
Immune phenotype-genotype associations in primary clear cell renal cell carcinoma and matched metastatic tissue (download .pdf)
Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs (download .pdf)
Systematic comparison of sequencing-based spatial transcriptomic methods (download .pdf)
Benefits for children with suspected cancer from routine whole-genome sequencing (download .pdf)
A prognostic and predictive computational pathology immune signature for ductal carcinoma in situ: retrospective results from a cohort within the UK/ANZ DCIS trial (download .pdf)
The limits of fair medical imaging AI in real-world generalization (download .pdf)
Artificial intelligence for cancer screening and surveillance (download .pdf)
A whole-slide foundation model for digital pathology from real-world data (download .pdf)
Costs of Drug Development and Research and Development Intensity in the US, 2000-2018 (download .pdf)
ESMO Recommendations on clinical reporting of genomics test results for solid cancers (download .pdf)
A survey of skin tone assessment in prospective research (download .pdf)
Identification and validation of a machine learning model of complete response to radiation in rectal cancer reveals immune infiltrate and TGFβ as key predictors(download .pdf)
A retrospective analysis of treatment patterns, overall survival, and real-world disease-free survival in early-stage non-small cell lung cancer following complete resection (download .pdf)
Predicting breast cancer types on and beyond molecular level in a multi-modal fashion (download .pdf)
Democratizing Artificial Intelligence in Anatomic Pathology (download .pdf)
Recent Clinical Implications of FAPI Imaging and Therapy (download .pdf)
SPLICE - Streamlining Digital Pathology Image Processing (download .pdf)
Towards an Interoperability Landscape for a National Research Data Infrastructure for Personal Health Data (download .pdf)
Targeting conserved TIM3+VISTA+ tumor-associated macrophages overcomes resistance to cancer immunotherapy (download .pdf)
Evaluation and mitigation of the limitations of large language models in clinical decision-making (download .pdf)
Real-World Impact of Comprehensive Genomic Profiling on Biomarker Detection, Receipt of Therapy, and Clinical Outcomes in Advanced Non–Small Cell Lung Cancer (download .pdf)
Validation of prostate and breast cancer detection artificial intelligence algorithms for accurate histopathological diagnosis and grading: a retrospective study with a Japanese cohort (download .pdf)
Multimodal Prototyping for cancer survival prediction (download .pdf)
Modeling Dense Multimodal Interactions Between Biological Pathways and Histology for Survival Prediction (download .pdf)
Morphological Prototyping for Unsupervised Slide Representation Learning in Computational Pathology (download .pdf)
A foundation model for clinical-grade computational pathology and rare cancers detection (download .pdf)
Learning generalizable AI models for multi-center histopathology image classification (download .pdf)
Hidden flaws behind expert-level accuracy of multimodal GPT-4 vision in medicine (download .pdf)
The ethics of ChatGPT in medicine and healthcare: a systematic review on Large Language Models (LLMs) (download .pdf)
Ketogenic diet administration later in life improves memory by modifying the synaptic cortical proteome via the PKA signaling pathway in aging mice (download .pdf)
Navigating Challenges and Opportunities in Multi-Omics Integration for Personalized Healthcare (download .pdf)
The Picasso’s skepticism on computer science and the dawn of generative AI: questions after the answers to keep “machines-in-the-loop” (download .pdf)
HER2 quantitative continuous scoring for accurate patient selection in HER2 negative trastuzumab deruxtecan treated breast cancer (download .pdf)
WHO
New study shows effectiveness of low-cost portable device for treating cervical precancers (download .pdf)
PNPL
Micro Highlight: Implementing and Assessing Process Improvements in the Gross Room (download .pdf)
Implementing and Assessing Process Improvements in the Gross Room (download .pdf)
Resources
The ARTICULATE PRO Study (download .pdf)
The Environment and Disease: Association or Causation? (download .pdf)
Assessing Radiology Research on Artificial Intelligence: A Brief Guide for Authors, Reviewers, and Readers—From the Radiology Editorial Board (download .pdf)
What is CMS’ authority regarding Laboratory Developed Tests (LDTs) and how does it differ from FDA’s authority? (download .pdf)
Labs juggle string of LDT unknowns (download .pdf)
Resilient Artificial Intelligence in Health: Synthesis and Research Agenda Toward Next-Generation Trustworthy Clinical Decision Support (download .pdf)
Analytical Validation of the Multitarget Stool RNA Test for Colorectal Cancer Screening (download .pdf)
Interoperability of Real-Time Public Safety Data: Challenges and Possible Future States (download .pdf)
Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile (download .pdf)
Interoperability of Real-Time Public Safety Data: Challenges and Possible Future States (download .pdf)
Cost Drivers in the Development and Validation of Biomarkers Used in Drug Development (download .pdf)
M14 General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines (download .pdf)
DPYD Genotyping Recommendations: A Joint Consensus Recommendation of the Association for Molecular Pathology, American College of Medical Genetics and Genomics, Clinical Pharmacogenetics Implementation Consortium, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, European Society for Pharmacogenomics and Personalized Therapy, Pharmacogenomics Knowledgebase, and Pharmacogene Variation Consortium (download .pdf)
